Douglas MacKay

In this paper, I explore the ethics of subject selection in the context of biomedical research. I reject a key principle of what I shall refer to as the standard view. According to this principle, investigators should select participants so as to minimise aggregate risk to participants and maximise aggregate benefits to participants and society. On this view, investigators should exclude prospective participants who are more susceptible to risk than other prospective participants. I argue instead that investigators should select subjects in accordance with an alternative principle: formal equality of opportunity. According to this principle, investigators must treat all prospective participants the same unless differential treatment is warranted by the scientific goals of the study or the need to promote participants' medically related interests. All prospective participants (1) who meet the scientifically defined eligibility criteria and (2) for whom participation is consistent with their medically related interests should have an equal, formal opportunity to participate in the study. Prospective participants should not be excluded simply because they are more susceptible to risk than others.

Controlled human infection (CHI) studies involve the deliberate exposure of healthy research participants to infectious agents to study early disease processes and evaluate interventions under controlled conditions with high efficiency. Although CHI studies expose participants to the risk of infection, they are designed to offer investigators unique advantages for studying the pathogenesis of infectious diseases and testing potential vaccines or treatments in humans. One of the central challenges facing investigators involves the fair selection of research subjects to participate in CHI studies. While there is widespread agreement that investigators have a duty to select research participants fairly, this principle also yields conflicting ethical imperatives, for example requiring investigators to both exclude potential participants with co‐morbidities since they face increased risks, but also to include them in order to ensure generalizability. In this paper we defend an account of fair subject selection that is tailored to the context of CHI studies. We identify the considerations of fairness that bear directly on selecting participants for CHI studies and provide investigators and members of IRBs and RECs with a principled way to navigate the conflicting imperatives to which these considerations give rise.

Political philosophers often formulate the problem of distributive justice as the problem of how the government ought to distribute different types of goods—for example, income or health care—to its citizens. They therefore presuppose that the government is a unitary agent that governs its citizens directly. However, although a number of governments are unitary in this way, many are federations, exhibiting a division of sovereignty between two or more levels of government having independent grounds of authority. In contrast to unitary states, therefore, within a federation, two or more levels of government directly govern their citizens and are directly accountable to them. Because of the way in which different levels of government in a federation can separately affect the distribution of goods in society, federations face resource allocation problems that are far more complex than those of unitary states. In addition to determining what a just distribution of goods is, federations must also determine (1) whether distributive justice is a shared responsibility amongst different levels of government, and, if so, (2) how this shared responsibility should be allocated between them.

Hospital systems commonly face the challenge of determining just ways to allocate scarce drugs during national shortages. There is no standardised approach of how this should be instituted, but principles of distributive justice are commonly used so that patients who are most likely to benefit from the drug receive it. As a result, clinical indications, in which the evidence for the drug is assumed to be established, are often prioritised over research use. In this manuscript, we present a case of a phase II investigational trial of intravenous thiamine for delirium prevention in patients undergoing haematopoietic stem cell transplantation to emphasise several shortcomings in the overarching prioritisation of clinical over research uses of scarce drugs. Specifically, we present the following considerations: clinical use may not have stronger evidence than research use; a strong scientific rationale for research use may outweigh the claim for clinical indications in which there is weak evidence; treatment within the context of a clinical trial may be the standard of care; and research use may not only benefit patients receiving the treatment but also offers the prospect of improving future clinical care. In summary, we argue against allocation schemes that prohibit all research uses of scarce drugs and instead recommend that allocation schemes include a balanced approach that weighs risks and benefits of access to scarce drugs irrespective of the research versus clinical use designation.

In a carefully argued article, Haley K. Sullivan and Benjamin E. Berkman address the important question of whether investigators have a duty to report incidental findings to research participants in low‐resource settings. They suggest that the duty to rescue offers the most plausible justification for the duty to return incidental findings, and they explore the implications of this duty for the context of research in low‐resource settings. While I think they make valuable headway on an important problem, in this commentary, I identify a significant difference between the paradigmatic rescue case and the return of incidental findings in low‐resource settings. This difference, I suggest, implies that their framework may be too narrow in scope. If investigators (and their sponsors) really wish to fulfill their duty to rescue, they must consider factors that are left out of Sullivan and Berkman's framework.

The problem of standard of care in clinical research concerns the level of treatment that investigators must provide to subjects in clinical trials. Commentators often formulate answers to this problem by appealing to two distinct types of obligations: professional obligations and natural duties. In this article, I investigate whether investigators also possess institutional obligations that are directly relevant to the problem of standard of care, that is, those obligations a person has because she occupies a particular institutional role. I examine two types of institutional contexts: (1) public research agencies – agencies or departments of states that fund or conduct clinical research in the public interest; and (2) private‐for‐profit corporations. I argue that investigators who are employed or have their research sponsored by the former have a distinctive institutional obligation to conduct their research in a way that is consistent with the state's duty of distributive justice to provide its citizens with access to basic health care, and its duty to aid citizens of lower income countries. By contrast, I argue that investigators who are employed or have their research sponsored by private‐for‐profit corporations do not possess this obligation nor any other institutional obligation that is directly relevant to the ethics of RCTs. My account of the institutional obligations of investigators aims to contribute to the development of a reasonable, distributive justice‐based account of standard of care.